MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 2-LUMEN CANNULA V; SINGLE USE BILIARY STENT

Model Number	PR-V614M
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The suspect device was sent to an olympus service center for evaluation.Inspection and testing confirmed the reported event.The marking areas at the distal end of the tube were peeled in the longitudinal direction of the tube.The markings did not rise from the surface and no peelings were observed when touching the area using fingers.A review of the device history record found no deviations that could have caused or contributed to the peeled markings.There were no anomalies noted with regard to the appearance of the marking areas.Based on the results of the legal manufacturer's investigation, it is likely the peeling markings were due to the device being inserted into/withdrawn from the endoscope while the forceps elevator was highly raised which caused the marking area to be rubbed from the contact with the forceps elevator or the distal end of the endoscope resulting in peeling of the marking.However, a definitive root cause of the reported issue could not be identified.The device's instruction manual provides the following warning, which may help to prevent the issue: "do not extend or insert the instrument abruptly, and do not force the instrument if resistance to insertion is encountered.Reduce the angulation or lower the forceps elevator of the endoscope until the instrument passes smoothly.Otherwise, patient injury, such as punctures, hemorrhages or mucous membrane damage could occur.It could also damage the endoscope and/or instrument." "do not advance or extend the instrument abruptly.This could cause patient injury, such as punctures, hemorrhages or mucous membrane damage.It may also damage the endoscope and/or instrument." "insert the instrument slowly.Abrupt insertion could damage the endoscope and/or instrument." "do not withdraw the instrument from the endoscope if the forceps elevator is up.This could damage the instrument." "if resistance is too strong and withdrawal is difficult, adjust the angle of the endoscope until the instrument can be withdrawn smoothly.Forcible withdrawal could damage the instrument or endoscope." olympus will continue to monitor field performance for this device.
Event or Problem Description
The customer reported that, during a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure, part of the markings on the subject device were peeled off.The device was removed from the endoscope and the procedure was completed with another device of the same model.There was no debris in the body and there was no harm or user injury reported due to the event.

• Brand Name: SINGLE USE 2-LUMEN CANNULA V
• Common Device Name: SINGLE USE BILIARY STENT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14802128
• Report Number: 8010047-2022-10767
• Device Sequence Number: 4961365
• Product Code: ODD
• UDI-Device Identifier: 04953170225000
• UDI-Public: 04953170225000
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950729
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PR-V614M
• Device Lot Number: 16K07
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2021
• Initial Report FDA Received Date: 06/24/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown